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Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)

This study has been completed.
Information provided by:
Otsuka Frankfurt Research Institute GmbH Identifier:
First received: September 19, 2005
Last updated: September 26, 2007
Last verified: September 2007
The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Condition Intervention Phase
Ulcerative Colitis Device: Adacolumn Apheresis System Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Otsuka Frankfurt Research Institute GmbH:

Primary Outcome Measures:
  • Primary Outcomes: Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score; Safety will be evaluated by determining the frequency and severity of adverse events.

Estimated Enrollment: 42
Study Start Date: June 2005
Estimated Study Completion Date: June 2006
Detailed Description:
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00219414

Sponsors and Collaborators
Otsuka Frankfurt Research Institute GmbH
Principal Investigator: Robert Lofberg, Prof. IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden
Principal Investigator: Toshifumi Hibi, Prof. Keio University, Tokyo, Japan
  More Information Identifier: NCT00219414     History of Changes
Other Study ID Numbers: 512-04-205-CS
Study First Received: September 19, 2005
Last Updated: September 26, 2007

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases processed this record on August 23, 2017